16.19.30 NMAC

TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING

CHAPTER 19 PHARMACISTS

PART 30 COMPOUNDING OF NON-STERILE PHARMACEUTICALS

16.19.30.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy

[16.19.30.1 NMAC - N, 09-15-06]

16.19.30.2 SCOPE: All pharmacies as defined in 61-11-2 (S), (Y) NMSA 1978, and all persons or entities that own or operated, or are employed by a pharmacy for the purpose of providing pharmaceutical products or services.

[16.19.30.2 NMAC - N, 09-15-06]

16.19.30.3 STATUTORY AUTHORITY: Sections 61-11-9(A)(6) NMSA 1978 requires that the board of pharmacy provide for the licensing or retail pharmacies and nonresident pharmacies and for the inspection of their facilities and activities.

[16.19.30.3 NMAC - N, 09-15-06]

16.19.30.4 DURATION: Permanent

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16.19.30.5 EFFECTIVE DATE: 09-15-06, unless a later date is cited at the end of a section.

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16.19.30.6 OBJECTIVE: The objective of part 30 of chapter 19 is to provide standards for the compounding of non-sterile pharmaceuticals. Pharmacies compounding non-sterile pharmaceuticals shall comply with the requirements of this section in addition to all provisions for their specific license classification.

[16.19.30.6 NMAC - N, 09-15-06]

16.19.30.7 DEFINITIONS: In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise.

A. “Beyond-use date” the date after which a compounded preparation should not be used and is determined from the date the preparation was compounded.

B. “Component” any ingredient intended for use in the compounding of a drug product, including those that may not appear in such product labeling.

C. “Compounding” the preparation, mixing assembling, packaging, or labeling of a drug or device (reconstitution of commercial products is not considered compounding for purposes of this article).

(1) as the result of a practitioner’s prescription order, based on the practitioner-patient-pharmacist relationship in the course of professional practice;

(2) preparing limited quantities of prescription orders based upon a history of receiving valid prescriptions issued within an established practitioner-patient-pharmacist relationship in the course of professional practice;

(3) reconstitution of commercial products not considered compounding for purpose of this article.

D. “FDA” Food and Drug Administration.

E. “SOP’s” standard operating procedures.

F. “USP/NF” the current edition of the United States Pharmacopeia/National Formulary.

[16.19.30.7 NMAC - N, 09-15-06]

16.19.30.8 PERSONNEL:

A. Pharmacist-in-charge. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following concerning non-sterile compounding:

(1) determining that all personnel involved in non-sterile compounding possess the education, training, and proficiency necessary to properly and as safely perform compounding duties undertaken or supervised;

(2) determining that all personnel involved in non-sterile compounding obtain continuing education appropriate for the type of compounding done by the personnel;

(3) assuring that the equipment used in compounding is properly maintained;

(4) maintaining an appropriate environment in the area where non-sterile compounding occurs and;

(5) assuring that effective quality control procedures are developed and followed.

B. Pharmacists. Special requirements for non-sterile compounding;

(1) all pharmacists engaged in compounding shall:

(a) possess the education, training and proficiency necessary to properly and safely perform compounding duties undertaken or supervised and

(b) obtain continuing education for the type of compounding done by the pharmacist.

(2) A pharmacist shall inspect and approve all components, drug product containers, closures, labeling and any other material involved in the compounding process.

(3) A pharmacist shall review all compounding records for accuracy and conduct in-process and final checks to assure that errors have not occurred in the compounding process.

(4) A pharmacist is responsible for the proper maintenance, cleanliness and use of all equipment used in the compounding process.

C. Pharmacy technicians. All technicians engaged in compounding shall:

(1) possess the education, training and proficiency necessary to properly and safely perform compounding duties undertaken;

(2) obtain continuing education for the type of compounding done by the pharmacy technician; and

(3) perform compounding duties under the direct supervision of and responsible to a pharmacist.

D. Training. All personnel involved in non-sterile compounding shall be trained and must participate in continuing relevant training programs.

[16.19.30.8 NMAC - N, 09-15-06]

16.19.30.9 OPERATIONAL STANDARDS:

A. General requirements.

(1) Non-sterile drug products may be compounded in licensed pharmacies as a result of a practitioner’s prescription order based on the practitioner-patient-pharmacist relationship in the course of professional practice.

(2) Preparing limited quantities of prescription drug orders in anticipation based upon a history of receiving valid prescriptions issued within an established practitioner-patient-pharmacist relationship in the course of professional practice.

(a) The beyond-use date should be based on the criteria outlined in USP Chapter <795>.

(b) Any product compounded in anticipation of future prescription drug or medication orders shall be labeled. Each label shall contain:

(i) name and strength of the compounded medication or list of the active ingredient and strengths;

(ii) facility’s lot number;

(iii) beyond-use date;

(iv) quantity or amount in the container.

(3) Commercially available product may be compounded for dispensing to individual patients provided the following conditions are met:

(a) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet patient’s needs; and

(b) the prescribing practitioner has requested that the drug be compounded; or

(c) if the compounded product is changed to produce for that patient a significant difference, as authorized by the prescriber, between the compounded drug and the comparable commercially available drug product, or if use of the compounded product is in the best interest of the patient; “significant difference” would include the removal of a dye for medical reason such as an allergic reaction; when a compounded product is to be dispensed in place of a commercially available product, the prescriber and patient shall be informed that the product will be compounded.

(4) Compounding for a prescriber’s office use.

(a) Pharmacies may prepare compounding drug products for a duly authorized prescriber’s office use.

(b) An order by the duly authorized prescriber, indicating the formula and quantity ordered will be filed in the pharmacy.

(d) A record of the compounded drug product may be kept as a prescription record in the pharmacy computer or by hard-copy record.

(e) A label may be generated and a number assigned by the pharmacy computer for the compounded drug product.

(5) Compounding veterinarian products.

(a) Prescriptions for animals may be compounded based on an order or prescription from a duly authorized veterinarian.

(b) These prescriptions are to be handled and filled the same as the human prescriptions.

(6) Compounding pharmacies/pharmacists may advertise and promote the fact that they provide non-sterile prescription compounding services which may include specific drug products and classes of drugs.

B. Environment.

(1) Pharmacies regularly engaging in compounding shall have a designated and adequate area for the safe and orderly compounding of drug products including the placement of equipment and materials. Pharmacies involved in occasional compounding shall prepare an area prior to each compounding activity, which is adequate for safe and orderly compounding.

(2) Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of a drug compounding operation.

(3) A sink with hot and cold running water, exclusive of rest room facilities, shall be accessible to the compounding areas and be maintained in a sanitary condition.

(4) When drug products that require special precautions to prevent contamination, such as penicillin, are involved in a compounding operation, appropriate measures, including dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its’ use for the preparation of other drug products, must be used in order to prevent cross-contamination.

C. Equipment and Supplies. The pharmacy shall:

(1) have a class A prescription balance, or analytical balance and weights when necessary which shall be properly maintained and subject to inspection by the New Mexico board of pharmacy and;

(2) have equipment and utensils necessary for the proper compounding of prescription or medication drug orders; such equipment and utensils used in the compounding process shall be:

(a) of appropriate design and capacity, and be operated within designated operational limits;

(b) of suitable composition so that surfaces that contact components, in-process material or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug product beyond the desired result;

(d) routinely inspected, calibrated when necessary or checked to ensure proper performance.

D. Labeling. In addition to the labeling requirements of the pharmacy’s specific license classification, the label dispensed or distributed pursuant to a prescription or medication drug order shall contain the following:

(1) the generic name(s) or the designated name and the strength of the compounded preparation;

(2) the quantity dispensed;

(3) the date on which the product was compounded;

(4) a lot or batch number, and;

(5) the beyond-use date after which the compounded preparation should not be used;

(a) in the absence of stability information applicable for a specific drug in the USP/NF the preparation shall adhere to the following maximum beyond-use date guidelines:

(i) non-aqueous liquids and solid formulations (where the manufactured drug product is the source of active ingredient) 25% of the time remaining until the manufacturer’s product’s expiration date or six (6) months, whichever is earlier;

(ii) water-containing formulations (prepared from ingredients in solid form) not later than fourteen (14) days when refrigerated between 2-8 degrees Celsius or 36-46 degrees Fahrenheit;

(iii) all other formulations: intended duration of therapy or 30 days, whichever is earlier;

(b) beyond-use date limits may be exceeded when supported by valid scientific stability information for the specific compounded preparation.

E. Drugs, components and material used in non-sterile compounding.

(1) Drugs used in non-sterile compounding shall preferably be a USP/NF grade substance manufactured in a FDA registered facility.

(2) In the event that USP/NF grade substances are not available, documentation of stability and purity must be established and documented.

(3) A pharmacy may not compound a drug product which has been withdrawn or removed from the market for safety reasons.

F. Compounding Process. The safety, quality and performance of compounded prescriptions depend on correct ingredients and calculations, accurate and precise measurements, appropriate formulation conditions and procedures, and prudent pharmaceutical judgment. Each pharmacy shall develop and follow written SOP’s based on established compounding procedures as outlined in chapter 795 of the USP/NF concerning pharmacy compounding of non-sterile preparations designed to ensure accountability, accuracy, quality, safety, and uniformity in the compounding process.

G. Quality Control.

(1) The safety, quality, and monitoring is used to insure that the output of compounded drug products for uniformity and consistency such as capsule weight variations, adequacy of mixing, clarity or pH of solutions are met. When developing these procedures, pharmacy personnel shall consider the provisions of Chapter 795 of the USP/NF concerning pharmacy compounding of non-sterile preparations, chapter 1075 of the USP/NF concerning good compounding practices, and chapter 1160 of the USP/NF concerning pharmaceutical calculations in prescription compounding. Such procedures shall be documented and be available for inspection.

(2) Compounding procedures that are routinely performed, including batch compounding, shall be completed and verified according to written procedures. The act of verification of a compounding procedure involves checking to ensure that calculations, weighing and measuring, order of mixing, and compounding techniques were appropriate and accurately performed.

(3) Unless otherwise indicated or appropriate, compounded preparations are to be prepared to ensure that each preparation shall contain not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated and labeled quantity of active ingredient per unit volume and not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated weight or volume per unit of the preparation.

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16.19.30.10 RECORDS:

A. Maintenance of records. Every record required by this section shall be kept by the pharmacy for at least three (3) years.

B. Compounding records.

(1) Formulation records:

(a) provides a consistent source document for preparing the preparation (recipe);

(b) is a file of individual compounded preparations;

(d) must list all ingredients and their quantities;

(e) must list equipment needed to prepare the preparation, when appropriate, and mixing instructions;

(f) other environmental controls, such as the duration of mixing and other factors pertinent to the replication of the preparation as compounded; and

(g) must contain beyond-use date and methodology, the container used in dispensing, the storage requirements, and any quality control procedures.

(2) Compounding records:

(a) document the actual ingredients in the preparation and the person responsible for the compounding activity;

(b) contain the name and strength of the compounded preparation, the formulation record reference for the preparation, and the sources and lot numbers of the ingredients;

(c) contain information on the total number of dosage units compounded, the name of the person who prepared the preparation and the name of the pharmacist who approved the preparation;

(d) contain the date of the preparation, the assigned internal identification number or the prescription number and an assigned beyond-use date; and

(e) for all compounded preparations, results of quality control procedures are to be recorded.

[16.19.30.10 NMAC - N, 09-15-06]

History of 16.19.30 NMAC; [RESERVED]